The investigators initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to explore the safety and efficacy of different dose of Anakinra compared to standard medical care for patients with acute ischemic stroke who have achieved successful recanalization after endovascular thrombectomy.
Age between 18-80 years old (both inclusive);
Acute ischemic stroke symptom onset within 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
Pre-stroke modified Rankin scale (mRS) score ≤1;
Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (both inclusive);
Allergy to Anakinra;
NIHSS consciousness score 1a >2, or epileptic seizure, hemiplegia after seizures (Todd's palsy) or other neurological/mental illness such that the patient is not able to cooperate or unwilling to cooperate;
Unable to perform CTP or PWI;
Acute or past intracerebral hemorrhage (ICH) (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma) confirmed by CT or MRI;
Parallel
High-dose Anakinra
Drug100 mg loading dose Anakinra over 60 seconds within 0.5 hours after randomization, followed by consecutive 2 mg/kg/h infusions over 24 hours.
Low-dose Anakinra
Drug100 mg subcutaneous Anakinra over 60 seconds within 0.5 hours after randomization, followed by 100 mg administered twice daily for 3 days.
Standard medical treatment
Other interventionAdministration of standard medical treatment should be done according to routine clinical practice and current international guidelines.
Infarct core growth reduction via magnetic resonance imaging (MRI) at 5-7 days
Ordinal distribution of modified Rankin Scale (mRS) at 90 days
Ordinal distribution of mRS at 90 days (shift analysis). The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
The proportion of patients who have a score of 0 or 1 on the modified Rankin Scale (mRS) at 90 days
The proportion of patients with an mRS score ≤ 1 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
The proportion of patients with an modified Rankin Scale (mRS) score of 0-2 at 90 days
The proportion of patients with an mRS score of 0-2 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
The proportion of patients with an modified Rankin Scale (mRS) score of 5-6 at 90 days
The proportion of patients with an mRS score of 5-6 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
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